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www.ema.europa.eu EMA’s human medicines committee (CHMP) has recommended extending the therapeutic indication of Uplizna (inebilizumab) to include the treatment of adult patients with active immunoglobulin G4-related disease (IgG4-RD).IgG4-RD is a rare, chronic, autoimmune condition (a...
www.ema.europa.eu 14 new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended 14 medicines for approval at its September 2025 meeting.The committee recommended granting a marketing authorisation for Enflonsia (clesrovimab), a medicine indicated for the...
www.ema.europa.eu CVMP opinions on veterinary medicinal productsThe Committee adopted, by majority, a positive opinion for a marketing authorisation from Zoetis Belgium for Portela (relfovetmab), for the alleviation of pain associated with osteoarthritis in cats.The Committee adopted, by...
www.ema.europa.eu EMA's Management Board has unanimously approved the renewal of the mandate of the Agency’s Executive Director Emer Cooke, extending her tenure until 30 April 2027.The Board's decision follows the successful completion of the renewal process which was initiated by the...
www.ema.europa.eu Review will assess risk of leukoencephalopathy, a condition affecting the brainEMA’s safety committee (PRAC) has started a review of medicines containing levamisole, authorised in four countries of the European Union (EU) to treat infections caused by parasitic worms in...
www.ema.europa.eu EMA and the Heads of Medicines Agencies (HMA) are warning the public about the growing threat of illegal medicines being advertised and sold online across the European Union (EU).In recent months there has been a sharp rise in the number of illegal medicines marketed as...